Peripheral Nerve Stimulation to Reduce Hypoxic Events
Status: | Completed |
---|---|
Conditions: | Pulmonary |
Therapuetic Areas: | Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 11/17/2018 |
Start Date: | October 12, 2015 |
End Date: | January 19, 2017 |
A Randomized Control Trial of the Oxistimulator as an Adjunct to Standard Practice to Decrease Extent and Duration of Oxygen Desaturation in Adult Patients Who Have Received Anesthetics or Are Receiving Sedating Medications
This study is designed to determine if using peripheral nerve stimulation in conjunction with
pulse oximetry as an adjunct to traditional monitoring in the PACU reduces the frequency and
severity of sedation related apnea and hypoxic events.
pulse oximetry as an adjunct to traditional monitoring in the PACU reduces the frequency and
severity of sedation related apnea and hypoxic events.
The primary effectiveness objective is to determine if transcutaneous stimulation will
generate a respiratory response capable of reducing the extent and duration of oxygen
desaturations in patients with presumed risk of obstructive sleep apnea (OSA) who have
received some form of anesthesia or sedation. The primary safety objective is the
demonstration that the peripheral nerve stimulation is safe for the use of preventing or
reducing the sedation related hypoxemic events.
generate a respiratory response capable of reducing the extent and duration of oxygen
desaturations in patients with presumed risk of obstructive sleep apnea (OSA) who have
received some form of anesthesia or sedation. The primary safety objective is the
demonstration that the peripheral nerve stimulation is safe for the use of preventing or
reducing the sedation related hypoxemic events.
Inclusion Criteria
- Males and females > 18 yrs old
- Flemon's Score > 15
- Able to provide written informed consent
- Having gynecological, colorectal, orthopedic surgery, and urologic surgeries
- Baseline oxygen saturation on room air > 96%
Exclusion Criteria:
- Peripheral neuropathy involving the upper extremities
- Procedures requiring direct admission to the ICU or any site other than the
post-anesthesia care unit from the OR
- Diagnosed obstructive sleep apnea (OSA) and / or use of continuous positive airway
pressure (CPAP) or biphasic positive airway pressure (BiPAP) in the PACU.
- Presence of any implantable electric devices, including internal defibrillators,
pacemakers, or left ventricular assist device (LVAD)
- Post-procedure temperature < 35.5 Celsius or evidence of vasoconstriction
- Presence of metal hardware in either arm or in either shoulder
- Patients lacking access to the bare skin on an arm after surgery.
- History of atrial fibrillation
- History of bundle branch block
- Females from menarche to menopause that do not have a current negative pregnancy test
or surgical history preventing pregnancy.
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